Recent warnings about Chinese biopharma partners from members of Congress and U.S. intelligence officials have reached a fever pitch in Washington.
If it hasn’t become painfully obvious yet with the BIOSECURE Act in the news, China is aggressively pursuing a strategy to become the world’s leader in biotechnology, which poses a significant threat to U.S. national security. In recent months, members of Congress and U.S. intelligence officials have warned that Chinese biotech companies may be collaborating with Beijing, with the latest example being WuXi AppTec, a China-based biotech reported to have allegedly transferred a U.S. client’s intellectual property (IP) to the Chinese government without consent.
In its annual threat assessment in February 2024, the Office of the Director of National Intelligence (ODNI) warned that Beijing is prioritizing biotech and is trying to fast track its science and technology development through IP theft and other means for economic, political and military advantage.
“China now rivals the United States in DNA-sequencing equipment and some foundational research. Beijing’s large volume of genetic data potentially positions it to lead in precision medicine and agricultural biotechnology applications,” according to the ODNI.
Last month, the National Security Commission on Emerging Biotechnology (NSCEB) issued a white paper laying out policy options for the federal government, including requiring the president to conduct a competitive analysis of the state of biotech infrastructure and technological advancement in the U.S. compared to its strategic adversaries.
“If the United States does not lead, others will, and we risk a future in which biotechnology undermines, rather than supports, U.S. national security. The People’s Republic of China intends to win the age of biology and is making significant investments and shrewd policy decisions with the intent to outpace the United States,” warned the NSCEB.
John Crowley, the new CEO of the industry lobby Biotechnology Innovation Organization (BIO), in an opinion piece in STAT News on Thursday made a similar case that the U.S. must maintain its biotech dominance in the interest of national security.
“The country must never be at risk of losing access to safe and effective medicines. That’s why BIO, the organization I lead, supports the BIOSECURE Act, which is aimed at securing America’s domestic biomanufacturing supply chain,” Crowley wrote. “We also announced [March 13] that WuXi AppTec, one of the Chinese companies regulated by the bill, would be ending its relationship with us.”
What a difference a week makes! Just last month, BIO said it didn’t support the BIOSECURE Act. Then in a March 5 letter to Attorney General Merrick Garland, Rep. Mike Gallagher (R-Wisc.), chair of the House Select Committee on the Chinese Communist Party, requested that the Department of Justice investigate lobbying by BIO on behalf of WuXi and against the BIOSECURE Act—actions that would raise “concerns that [BIO] is operating as an unregistered agent of a foreign principal while advancing the interests of the People’s Republic of China government.”
BIO’s about-face on WuXi and the BIOSECURE Act is mind-boggling. It certainly begs the question why it took a showdown with a member of Congress for BIO to support the BIOSECURE Act and for the lobbying group to part ways with WuXi.
Other Companies in Crosshairs
The BIOSECURE Act specifically names the BGI Group, MGI, Complete Genomics and WuXi, and it isn’t the only congressional bill targeting these companies. In the Senate, the Prohibiting Foreign Access to American Genetic Information Act of 2024 also seeks to implement a fast-track ban applied to the same four firms, as well as their subsidiaries, from receiving U.S. taxpayer dollars through federal contracts, grants and loans.
“The U.S. intelligence community has cited the Chinese Communist Party’s concerted efforts to acquire human genetic and related data through biotechnology companies, such as the BGI Group, as a serious threat to U.S. national security,” according to Senators Gary Peters (D-Mich.) and Bill Hagerty (R-Tenn.), who authored the legislation.
And the list of targeted Chinese biotech companies continues to grow. In the House of Representatives, Gallagher and Rep. Raja Krishnamoorthi (D-Ill.) wrote a March 29 letter to Defense Secretary Lloyd Austin urging the Department of Defense to add seven Chinese biotechs to DoD’s 1260H list of “problematic People’s Republic of China” companies, including Innomics, STOmics, Origincell, Vazyme Biotech and Axbio.
How will a crackdown on WuXi and other Chinese biotechs affect U.S.-based biopharma companies? Merck, Iovance Biotherapeutics and Kyverna Therapeutics have detailed interactions with the SEC about potential impacts on their future programs. A Kyverna spokesperson in an email statement to BioSpace said it is aware of the “ongoing concerns related to the BIOSECURE Act” and is “closely monitoring the developments.”
If that weren’t enough, another area of collaboration that could suffer from these high-profile tensions between the U.S. and China is in the hot area of antibody-drug conjugate (ADC) technology. However, Jake Van Naarden, president of Eli Lilly’s Loxo Oncology division, told BioSpace that nearly all major pharma companies have contract relationships in China and cautioned against “[throwing] the baby out with the bathwater” by shutting down cooperation on ADC and other drug development. Hopefully, cooler heads will prevail.
Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.
